510(k) K033563 ยท LOD Bone Cement
SMARTSET GHV GENTAMICIN BONE CEMENT
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 5, 2004 |
| Received | Nov 12, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033563
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2015 | DePuy Orthopaedics, Inc. SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in a Terminated |
MBB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.